NCT05394324已完成不适用
A Post-market Clinical Study to Collect Safety and Performance Data on Johnson & Johnson Surgical Vision Products
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,674
- 试验地点
- 13
- 主要终点
- BCDVA
研究概览
简要总结
Retrospective collection of data from medical records, multicenter, post-market clinical follow-up study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have been implanted with and/or undergone ophthalmic surgery using targeted JJSV products
- •Status post ophthalmic surgery between 1 day and 24 months for Year
- •Subsequent years after Year 1 will be between 1 day and 18 months.
排除标准
- •Concurrent participation (during the retrospective follow-up period) in an interventional (drug, device, biologic, etc.) clinical trial
- •Use of surgical devices not in accordance with the product labeling or indications for use
- •Degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that cause visual acuity losses to a level worse than 0.2 logMAR (0.63 decimal, 6/9.5 or 20/32 Snellen) during the retrospective data collection period
- •Use of systemic or ocular medications that may affect vision during the retrospective data collection period
- •Known ocular disease or pathology that, in the opinion of the investigator may confound study findings during the retrospective data collection period
- •Pregnancy, lactating, or other condition associated with hormonal fluctuation that could lead to refractive changes during the retrospective data collection period.
结局指标
主要结局
BCDVA
时间窗: up to 12 months post-operation
The proportion of eyes achieving 20/40 or better BCDVA.
Incidence of Adverse Events
时间窗: up to 12 months post-operation
incidence of adverse events that are specified in the ISO 11979-7 Safety and Performance Endpoints.
次要结局
未报告次要终点
研究者
研究点 (13)
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